Company |
Product |
Description |
Indication |
Status |
Date |
Actavis plc (Dublin) |
Generic Restasis |
Cyclosporine ophthalmic emulsion |
To increase tear production |
Actavis submitted an abbreviated new drug application to the FDA |
1/23/14 |
Bristol-Myers Squibb Co. (Princeton, N.J.) and Astrazeneca plc (London) |
Farxiga |
Dapagliflozin tablets; a sodium glucose co-transporter 2 inhibitor |
Type 2 diabetes |
FDA approved Farxiga tablets to improve glycemic control, along with diet and exercise |
1/9/14 |
Daiichi Sankyo Co. Ltd. (Tokyo) |
Edoxaban |
Once-daily direct Factor Xa inhibitor |
To prevent stroke and systemic embolic events in patients with nonvalvular atrial fibrillation |
An MAA was submitted to the EMA |
1/8/14 |
Dainippon Sumitomo Pharma Co. Ltd. (Osaka, Japan) and Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) |
Lurasidone |
A once-daily oral treatment |
Schizophrenia |
CHMP issued a positive opinion |
1/27/14 |
Dezima Pharma BV (Naarden, the Netherlands) |
TA-8995 |
CETP inhibitor |
Mild dyslipidemia |
Completed enrollment of its Phase IIb TULIP study in about 360 patients |
1/15/14 |
Eisai Inc. (Woodcliff Lake, N.J.) |
Amituximab |
Chimeric monoclonal antibody |
Malignant mesothelioma |
European Commission granted orphan drug status to amituximab |
1/23/14 |
Eisai Inc. (Woodcliff Lake, N.J.) |
Fycompa |
Perampanel; AMPA glutamate receptor antagonist |
Partial onset seizures |
Will be available in the U.S. beginning Jan. 6, 2014, following FDA approval in October 2012 |
1/3/14 |
Glaxosmithkline plc (London) |
Mekinist |
Trametinib |
Unresectable melanoma or metastatic melanoma |
FDA has approved Mekinist for use in combination with Tafinlar (dabrafenib) |
1/10/14 |
Helsinn Group (Lugano, Switzerland) |
Netupitant-palonosetron fixed-dose combination |
Highly selective NK1 receptor antagonist and a 5-HT3 receptor antagonist |
Cancer |
EMA determined that the MAA was valid for netupitant-palonosetron fixed-dose combination for cancer |
1/30/14 |
Ipsen SA (Paris) |
Somatuline Autogel/Somatuline Depot |
Lanreotide |
Carcinoid syndrome in patients with neuroendocrine tumors |
Phase III data showed a statistically significant reduction vs. placebo in the number of days in which immediate-release octreotide was used as a rescue medication, representing a mean difference of -14.8% (p = 0.017); Somatuline significantly improved the rates of complete/partial treatment success vs. placebo (p = 0.036) |
1/21/14 |
Janssen Research & Development LLC (Raritan, N.J.; a unit of Johnson & Johnson) |
Xarelto |
Rivaroxaban; an oral anticoagulant |
To reduce the risk of thrombotic cardiovascular events in acute coronary syndrome |
FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against approval |
1/21/14 |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
Vorapaxar |
Antiplatelet medicine; inhibits thrombin-induced platelet aggregation by inhibiting PAR-1 receptors on platelets |
To reduce atherothrombotic events in heart attack, stroke or transient ischemic attack patients |
FDA’s Cardiovascular and Renal Drugs Advisory Committee’s recommended approval of vorapaxar |
1/17/14 |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
Isentress |
Raltegravir; a new pediatric formulation |
HIV-1 infection |
FDA approved it |
1/9/14 |
Merck & Co. Inc. (Whitehouse Station, N.J.) and Alk-Abello A/S |
Ragwitek |
The sublingual ragweed allergy |
Ragweed allergy |
FDA committee recommended approval of Ragwitek, voting 6-2, with one abstention, with the age range of 18-65 being the contentious issue; the two negative votes would have been positive if the age range was 18-50 |
1/29/14 |
Nuvo Research Inc. (Mississauga, Ontario) |
Pennsaid |
Diclofenac sodium topical solution; a nonsteroidal anti-inflammatory drug 2% |
Osteoarthritis of the knee |
FDA approved the NDA |
1/21/14 |
Pfizer Inc. (New York) |
Dacomitinib |
Irreversible pan-HER kinase inhibitor |
Advanced non-small-cell lung cancer |
Top-line data from two phase III studies showed that neither trial met their primary objectives, with ARCHER 1009 failing to demonstrate statistically significant improvements in progression-free survival when compared to Tarceva, and NCIC CTG BR.26 missing its objective of prolonging overall survival vs. placebo |
1/28/14 |
Pfizer Inc. (New York) |
Chantix/Champix |
Varenicline |
Smoking cessation |
A new smoking-cessation clinical study assessing the efficacy and safety of Chantix/Champix met its primary and secondary endpoints |
1/22/14 |
Pfizer Inc. (New York) |
ALO-02 |
Oxycodone hydrochloride/naltrexone hydrochloride extended-release capsules |
Moderate to severe chronic low back pain |
Top-line results from a phase III study showed that the drug met the primary efficacy endpoint, demonstrating a statistically significant difference from placebo |
1/24/14 |
Roche AG (Basel, Switzerland) |
Roactemra |
Tocilizumab; subcutaneous formulation; humanized interleukin-6 receptor antagonist |
Moderate to severe active rheumatoid arthritis |
Received a positive opinion from the EMA's CHMP in patients who responded inadequately to or could not tolerate therapy with one or more disease-modifying antirheumatic drugs or tumor necrosis factor inhibitors |
1/3/14 |
Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) |
Vedolizumab |
A humanized monoclonal antibody antagonizing alpha4beta7 integrin |
Moderate and severe ulcerative colitis and Crohn's disease |
Entered two new phase III trials in Japan |
1/9/14 |
Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) |
Ixazomib |
Oral proteasome inhibitor |
Relapsed and/or refractory multiple myeloma |
Started the phase III TOURMALINE-MM1 global study; countries participating in the study include Australia, China, Japan, New Zealand, Singapore and South Korea |
1/23/14 |
Teva Pharmaceutical Industries Ltd. (Jerusalem) |
Copaxone |
Glatiramer acetate injection |
Multiple sclerosis |
FDA approved the sNDA for three-times-a-week Copaxone 40 mg/mL, a new dose. The new formulation will allow for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis; the 20 mg/mL will continue to be available; the daily subcutaneous injection was approved in 1996 |
1/30/14 |
|
Notes BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment. Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. The date indicated refers to the BioWorld Today issue in which the news item can be found. | |||||
